Kornimate/medical-research-clean huggingface dataset:
robotic-assisted versus conventional total knee arthroplasty(tka)

Conditions: Arthritis; Knee Arthropathy; Robotics

Summary: robotic-assisted total knee arthroplasty (tka) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of tka. although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the tka.

robotic-assisted tka was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. several comparative studies of conventional and robotic-assisted tkas demonstrated that improved alignment of the components was obtained after the robotic-assisted tkas than conventional tkas. to date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted tka, particularly in younger patients. it is crucial to determine whether improved alignment of the tka components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of tkas. the aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and ct scan results, and the survivorship of tka would be better after robotic-assisted tka than after conventional tka.

Eligibility criteria:
inclusion criteria: * end stage knee arthritis exclusion criteria: * mild knee deformity * inflammatory arthritis * foot and ankle disorder * dementia * hip disease * history of a stroke * older than 65 years of age
amh, glucose intolerance and metabolic syndrome in pcos

Conditions: Polycystic Ovary Syndrome

Summary: association between serum anti-mullerian hormone (amh) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (pcos)

* to study the association between serum anti-mullerian hormone (amh) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (pcos). * glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (ogtt). * metabolic syndrome is diagnosed by using the harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome. 1. elevated waist circumference (\> 80 cm in asian women) 2. elevated triglycerides (\> 150 mg/dl) 3. reduced hdl-cholesterol (\< 50 mg/dl) 4. elevated blood pressure )systolic \> 130 and/or diastolic \> 85 mmhg) 5. elevated fasting glucose ( \> 100 mg/dl) * percentage of glucose intolerance and metabolic syndrome in pcos women as well was any differences in parameters between pcos patients with and without glucose intolerance and metabolic syndrome will be analysed.

Eligibility criteria:
inclusion criteria: * pcos diagnosed by rotterdam criteria 2003 exclusion criteria: * pregnancy * previous any hormonal uses in the last 3 months * previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months * previous chemotherapy, ovarian surgery, pelvic irradiation * menopause

Keywords: polycystic ovary syndrome serum anti-mullerian hormone glucose intolerance metabolic syndrome
oral budesonide vs. oral mesalazine in active crohn's disease (cd)

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active crohn's disease.

crohn's disease is often treated with glucocorticoids or mesalazine. both drugs are indicated for active crohn's disease. treatment with mesalazine is indicated for the treatment of mildly to moderately active crohn's disease. budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses. so far only one trial compares the efficacy and safety of budesonide and 5-asa. the result of this trial is that budesonide is more effective in inducing remission than mesalazine. the primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. budenofalk® capsules (9 mg/day) and salofalk® tablets (eudragit-l-coated oral mesalazine; 4.5 g/day) in moderately active crohn's disease. mesalazine is used in this trial as a comparator.

Eligibility criteria:
inclusion criteria (main): * symptoms of crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria \[endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to vienna classification) should be unchanged compared to former episodes\] * localisation of cd either in terminal ileum, ascending colon or ileocolitis * active phase of disease (200 \< cdai \< 400) exclusion criteria (main): * known crohn's lesion in the upper gi-tract (up to and including the jejunum) with present symptoms * cd in the rectum currently present * short bowel syndrome * septic complications * baseline stool positive for germs causing bowel disease * abscess, perforation or active fistulas * ileostomy or colostomy * resection of more than 50 cm of the ileum * bowel surgery within the last 3 months * immediate surgery required * clinical signs of stricturing disease * subileus within the last 6 months * suspicion of ileus, subileus or corresponding symptomatology * contra-indications, special warnings and precautions mentioned in smpc * treatment with immunosuppressants, cytostatics, 6-tg, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-mp the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study * treatment with ketoconazole, ciprofloxacin or other cyp3a inhibitors within the last month before baseline visit * treatment with anti-tnf-a therapy within 6 months before baseline visit * conventional steroids (iv, po, rectal) within 2 weeks before the study * \> 6 mg/d budesonide po or \> 3 g/d mesalazine po within 2 weeks before the study * patients known to be steroid-refractory or steroid-dependent from former cd episodes * treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks
capnography monitoring in the bronchoscopic sedation

Conditions: Hypoventilation

Summary: procedure sedation of flexible bronchoscopy (fb) comforts patients undergoing fb. hypoventilation during fb is a concern. the investigators investigate the feasibility of monitoring capnography in fb sedation.

patients undergoing flexible bronchoscopy (fb) experience procedure-related symptoms. current guidelines of fb recommend sedation to all patients undergoing fb, except when there are contraindications. propofol or benzodiazepines plus an opioid are the common combination used to improve patient tolerance and satisfaction during fb. however, controversy about combining propofol and opioids persists because of the risk of over-sedation and cardiopulmonary depression. while transition from alert into sedation during induction, like sleep, the respiratory drive and muscle tone of respiratory muscle and upper airway attenuate, which contribute hypoventilation and upper airway collapse, and further hypoxemia. detection of cardiopulmonary depression traditionally has relied on continuous monitoring of heart rate, respiratory rate, and oxygen saturation. however, it has been shown that these monitors could not recognize hypoventilation early. similar with other published data, around 40% of hypoxemia event occurred during fb sedation in our hospital. further analysis of our data revealed around 15% event occurred during sedative induction. capnography is the noninvasive measurement of the partial pressure of carbon dioxide (co2) from the airway during ventilation. the maximum partial pressure of co2 obtained at the end of an exhaled breath is referred to as end-tidal co2 (etco2). studies have revealed the waveform analysis of capnography can provide early warning for prehypoxic respiratory depression in patients undergoing procedure sedation in emergency department and gastrointestinal endoscopy. therefore, capnography can serve as a real-time measure of ventilatory status of sedative patients and the physicians could intervene before the occurrence of hypoxemia. based on the advantage of non-invasive and real-time property of etco2 monitored by capnography, the investigators plan to conduct a clinical trial to evaluate if hypoxemia could be reduced by capnography of etco2 monitor during induction of fb sedation.

Eligibility criteria:
inclusion criteria: * patients undergoing elective bronchoscopy and sedation exclusion criteria: * age less than 18 years * american society of anaesthesiologists (asa) physical status classification iv or v * mallampati score of 4 * severe sleep apnoea syndrome (apnoea-hypopnea index more than 40) * body mass index more than 42 in males or 35 in females * neurologic disorders or other conditions contributing to difficulty in assessing response * forced expiratory vital capacity (fvc) less than 15 ml/kg body weight, forced expiratory volume in one second (fev1) less than 1000 ml, or fev1/fvc less than 35% * chronic use of opioid drugs * pregnancy * patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products

Keywords: hypoventilation capnography bronchoscopy
respiratory mechanics and pleural effusion

Conditions: Critically Ill; Acute Lung Injury; ARDS

Summary: the investigators aim to compare the respiratory mechanics in acute lung injury (ali)/acute respiratory diseases syndrome (ards) patients with and without pleural effusion.

in ali/ards we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with ct scan. thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.

Eligibility criteria:
inclusion criteria: * ali/ards patients underwent invasive mechanical ventilation exclusion criteria: * haemodynamic instability * chronic obstructive pulmonary disease (copd) patients

Keywords: critically ill patients
covid-19 epidemic lockdown impact on psychomotor performance

Conditions: Covid19 Epidemic Lockdown Impact

Summary: purpose: to detect the covid-19 epidemic lockdown impact on psychomotor performance in egyptian children. background: the corona virus disease (covid-19) affected virtually all countries including egypt as records showed 156,397 subjects including all age groups, adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. psychomotor disorders are expected during and aftermath of the pandemic. validated questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool. hypotheses: covid-19 epidemic lockdown has an impact on psychomotor performance in egyptian children. research question: does covid-19 epidemic lockdown impact on psychomotor performance in egyptian children?


Eligibility criteria:
inclusion criteria: 100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between 1. 6-9 years. 2. 10-13 years. 3. 14-18 years all subjects should be clinically and medically stable exclusion criteria: subjects with psychological or motor impairment will be excluded from the study.
chat at home pilot study

Conditions: Childhood Obesity

Summary: this study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). a factorial design (2 x 2 x 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via wifi-enabled scales.

all participants in this study will receive 10 core coaching sessions. these sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the bmi scale. the sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's bmi. in addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.

Eligibility criteria:
inclusion criteria: * parent/primary caregiver of child in the 8-12 year old age range based on child birth date * the child's bmi is greater than or equal to the 85th percentile according to cdc age and sex reference standards * child lives with parent/primary caregiver 50% of the time * willing to have a second caregiver participate in this study * wifi at home * the parent and child can speak, read, and understand english exclusion criteria: * kidney disease, type 1 diabetes, lupus, current cancer diagnosis, * chromosomal abnormality such as down's syndrome or turner's syndrome * child taken any steroid medications such as prednisone, prenisilone and decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids) * child enrolled in a different weight management program * family participating in any other child research study related to dietary intake, physical activity, weight * plans to move more than 50 miles from your present location within the next 6 months

Keywords: parent, adolescent, coaching, weight loss
navigator 1.5 accuracy study

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to confirm that the accuracy and safety of version 1.5 of the freestyle navigator continuous glucose monitoring system are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. it is anticipated that information collected will be submitted as a supplement to premarket approval application (p050020) to the us food and drug administration for approval to market this version of the system.


Eligibility criteria:
inclusion criteria: * history consistent with type 1 diabetes for at least 2 years prior to enrollment; * for at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections; * at least 18 years of age; * available and capable of following the protocol instructions provided by the healthcare professional; * signed and dated informed consent form. exclusion criteria: * pregnancy; * type 2, gestational, or secondary diabetes; * known allergy to medical grade adhesives or skin disinfectant; * skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin; * blood donation within 6 weeks prior to beginning study activities; * within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness; * active myocardial ischemia; * previous history of stroke; * any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety; * current participation in another clinical trial.

Keywords: continuous glucose monitoring accuracy continuous glucose error-grid analysis
use of antiseptic solution for vaginal wash before cesarean section

Conditions: Operation Wound; Infection; Endometritis

Summary: to evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).


Eligibility criteria:
inclusion criteria: * women with gestation between 34 and 41 6/7 weeks. * premature rupture of membranes (\> 6 hours). * use of prophylactic antibiotic 1 hour previous to cesarean section. exclusion criteria: * any source of infection diagnosed previous to surgery. * fever of unknown origin previous to surgery.

Keywords: cesarean operative site infection vaginal wash clorhexidine endometritis
effectiveness of laying-on-of-hands for sickle cell disease

Conditions: Sickle Cell Disease; Pain Crisis Recurrent; Anemia; Infection; Death

Summary: the objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in africa.

patients with sickle cell disease (scd) have a high risk of premature death in africa, mainly due to insufficient medical services. scd patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. there are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of scd patients, as far as we have investigated.

Eligibility criteria:
inclusion criteria: * patients with symptoms associated with sickle cell disease * those able to receive laying-on-of-hands every weekday for 1 year * those able to receive conventional medical treatment whenever necessary * those able to receive blood test at the beginning, after 6 month and after 1 year exclusion criteria: * those who wish to use other complementary and alternative therapies along with laying-on-of-hands

Keywords: sickle cell disease laying-on-of-hands morbidity mortality
cardioversion of short duration atrial fibrillation

Conditions: Atrial Fibrillation; Electrocardiography; Electrical Remodeling

Summary: the study is aimed at testing the hypothesis whether atrial fibrillary rate (afr), as a measure of atrial electrical remodeling assessed from surface ecg, is predictive of sinus rhythm maintenance after electrical cardioversion. earlier studies performed in a retrospective fashion suggested that high afr exceeding 350-360 fibrillations per minute is an independent predictor of af relapse after cardioversion, particularly in patients with duration of af episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study. casaf is an observational study that will enroll patients with short duration (\< 30 days) af admitted for electrical cardioversion. admission ecg will be extracted in a digital format and processed off-line for estimation of afr. af relapse will be assessed during 6-weeks long follow-up period during which ecg control will be scheduled at week 1 and 6.


Eligibility criteria:
inclusion criteria: * recurrent af verified by at least one ecg recording prior to the index admission * known onset of symptoms within 30 days from index admission. * sinus rhythm ecg within 30 days prior to the index admission if onset of symptoms is unknown. * if duration of the present af episode \>48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or tee performed to verify the lack of contraindications for electrical cardioversion. * echocardiography at any time since first onset of af to verify the lack of significant valvular disease. * age older than 18 years. exclusion criteria: * af due to reversible cause or significant valvular heart disease * treatment with class i or iii antiarrhythmic drugs within five half-lives of their elimination period. no amiodarone treatment within six months before admission * prior ablation of af * unability to verify onset of symptoms within 30 days prior to the index admission
myocardial perfusion magnetic resonance imaging using regadenoson

Conditions: Ischemic Heart Disease

Summary: this is a pilot study to determine whether the drug regadenoson can be used during magnetic resonance imaging to assess regions of poor blood flow to the heart. the hypothesis of this study is that a single injection of regadenoson could be used instead of a standard adenosine infusion to produce coronary vasodilatation and demonstrate myocardial ischemia during first-pass perfusion cardiac mri.

this is a pilot study that proposes to assess the feasibility of using regadenoson (lexiscan, astellas), a recently fda approved a2a receptor agonist, as the stress perfusion agent in cardiac mri perfusion examinations. while regadenoson has been approved by the fda, it has not been approved for the specific indications of use 1) during the simultaneous intravenous administration of a gadolinium-based contrast agent, or 2) during magnetic resonance imaging (mri). because this agent can be given intravenously in a single 400 microgram bolus, rather than in an infusion, this agent may be easier to administer than adenosine during an mri examination. the objectives for this pilot study are: 1) to demonstrate the feasibility of using regadenoson during cardiac perfusion mri to visualize known regions of myocardial ischemia as demonstrated on spect-mpi and 2) to describe a cardiac perfusion mri protocol using regadenoson that would have the potential to be used clinically.

Eligibility criteria:
inclusion criteria: * reversible perfusion abnormalities on a clinically ordered rest/adenosine dual-isotope spect-mpi in at least 2 contiguous myocardial segments (per 17-segment model) exclusion criteria: * myocardial infarction, myocardial revascularization procedure or progression in angina occuring after the spect-mpi examination * pregnancy * gadolinium-based mr contrast allergy * glomerular filtration rate (gfr) \> 60 ml/min/1.73 m2 * contraindications to mr imaging (pacemaker, brain aneurysm clips, schrapnel, etc.)

Keywords: myocardial ischemia, perfusion imaging, cardiac mri